Stereognosis training system and method for patients with chronic stroke, spinal cord injury or neuropathy

ABSTRACT

Provided is an effective stereognosis training system that integrates hardware and software to provide a simple, reliable, quantitative system to provide tactile rehabilitation and progress monitoring. The system can include an interactive device including a novel set of objects, that are combined with neuromodulatory systems such as wireless closed-loop vagus nerve stimulation to improve neural plasticity and expedite functional recovery. The system can send updates to therapists or clinicians to monitor progress and encourage compliance with prescribed therapy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/681,575 filed on Nov. 12, 2019, now U.S. Pat. No. 11,344,727 grantedon May 31, 2022, which claims priority to U.S. Provisional ApplicationNo. 62/855,648, filed May 31, 2019, and U.S. Provisional Application No.62/758,047, filed Nov. 9, 2018. Each patent application identified aboveis incorporated here by reference in its entirety to provide continuityof disclosure.

STATEMENT OF GOVERNMENT INTEREST

This invention was made with government support under grant numberR01-NS094384 awarded by the National Institutes of Health. Thegovernment has certain rights in the invention.

FIELD OF THE INVENTION

The present invention relates to a system and method for assessment ofand rehabilitation from peripheral nerve damage. More specifically, aunique stereognosis training system and methodology is disclosed. In apreferred embodiment, closed loop vagus nerve stimulation (CL VNS) ispaired with assessment of and/or rehabilitation from tactile sensorydysfunction in a patient.

BACKGROUND OF THE INVENTION

Nerve damage is a debilitating neurological disorder that affects overone hundred million people worldwide. Most traumatic nerve injuriesoccur in the upper extremities, resulting in profound motor and sensoryloss and chronic dysfunction of the arm and hand, which can severelyreduce quality of life. Despite advances in surgical repair andscaffolding techniques that promote regeneration, long-term prognosisfor most patients remains poor. There is a clear and present need todevelop interventional strategies that target alternative mechanismsbeyond nerve regeneration to restore function in patients after nerveinjury.

Immediately after traumatic nerve damage, physical disconnection resultsin loss of motor and sensory function. This peripheral damageprecipitates lasting changes throughout the central nervous system. Oneconsequence of nerve disruption is a sudden and dramatic imbalance ofsynaptic activity in regions of the brain and spinal cord that controlmotor and sensory function. This transient perturbation generatesprofound, long-lasting reorganization as these central networks attemptto compensate for altered peripheral connectivity. Pioneering studiesconducted over three decades ago demonstrated that synaptic connectionsfrom spared circuits strengthen and dominate central network activity inthe absence of competition from the denervated circuits. Over time,injured axons in the damaged nerve sprout, regrow, and establish newconnections with targets in the periphery. Despite reconnection ofperipheral axons to end targets (e.g., reinnervated muscle fibers andsensory receptors), chronic dysfunction of motor control and sensationoften persists. The inability for weakened reinnervated networks toovercome maladaptive central plasticity may contribute to lastingdysfunction.

Indirect evidence supports the role of insufficient central plasticityin chronic dysfunction following nerve injury. Compared to adults,children often display greater recovery despite a similar degree ofreinnervation inaccuracies after nerve injury, an effect partiallyattributed to a greater capacity for plasticity in children. Moreover,imaging studies in humans reveal long-term changes in brain structureand network function that associate with functional impairment. Ifinsufficient central plasticity after nerve damage contributes tochronic dysfunction after nerve damage, then techniques to enhanceplasticity and reestablish central network signaling should improvefunction, even in the absence of changes to the damaged nerve itself.

Sensory impairment of the hand is common after peripheral nerve damage,stroke, spinal cord injury, multiple sclerosis and other neurologicalconditions. Impaired proprioception, stereognosis and tactile sensationare common after stroke and are associated with poor functionaloutcomes.

Stereognosis, also known as haptic perception or tactile gnosis, is theability to perceive and recognize the form of an object, in the absenceof visual and auditory information, by using tactile information toprovide cues from texture, size, spatial properties, and temperature,etc. Astereognosis is the failure to identify or recognize objects bypalpation in the absence of visual or auditory information, even thoughtactile, proprioceptive, and thermal sensations may be unaffected.Astereognosis can be caused by damage to the posterior association areasof the parietal, temporal, or occipital lobes, or the postcentral gyrusof either hemisphere.

Tactile sensory function is driven by the somatosensory system whichprocesses stimulus such as texture, temperature, pressure etc. Thesomatosensory system is a complex system of sensory receptors thatrespond to internal or external stimulus and send sensory information tothe brain. Somatosensory receptors are classified into five primaryreceptor modalities, mechanoreceptors (touch), nociceptors (pain),thermoreceptors (temperature), proprioceptors (position and movement),and chemoreceptors (taste and smell). Proprioceptors are sensitive tothe stretch and tension of muscles, tendons, and joints. These receptorsallow us to calculate weight and movement.

Mechanoreceptors are found in the dermis or epidermis and are generallyassociated with the sensation of touch. Mechanoreceptors are broken upinto four specialized sensory receptor sub-modalities, Meissnercorpuscle, Pacinian corpuscles, Ruffini endings, and Merkel's disks.Meissner corpuscles are sensitive to fine tactile touch and are used tohelp determine texture. Pacinian corpuscles are sensitive to faststimulus, such as a jolt, fluttering or vibrating sensations. Ruffiniendings are sensitive to skin stretching or movement and give thefeeling of object slippage and finger position and control. Merkel'sdisks are responsive to deep and slow pressure and help determine shapesand edges.

There is no established method to restore tactile sensation afterperipheral nerve damage, stroke, spinal cord injury, multiple sclerosisand other neurological conditions. It is widely believed that patientsreceive inadequate sensory training to promote clinically significantrecovery of sensory function. Daily sensory training with a therapist orclinician is prohibitively expensive and requires significant time totravel to and from the clinic.

U.S. Pat. No. 8,489,185 to Kilgard, et al. discloses timing control forpaired plasticity. Kilgard discloses a closed loop timing control thatis communicably connected to a neural stimulation system and a sensor.

U.S. Pat. No. 8,700,145 to Kilgard, et al. discloses methods, systems,and devices for pairing vagus nerve stimulation with motor therapy instroke patients. Kilgard discloses a system that may be arranged in aclosed loop fashion so that stimulation is automatic, or arranged in anopen loop fashion where a therapist is required to intercede beforestimulation.

U.S. Publication No. 2018/0221666 to Rennaker, II, et al. disclosessystems and methods for optimizing targeted neuroplasticity. Rennakerdiscloses a closed loop system for optimizing learning having a vagusnerve stimulator configured to stimulate a vagus nerve of a person withan electrical pulse train; a controller configured to alter one or moreparameters of the electrical pulse train while maintaining otherparameters of the electrical pulse train constant; and a monitoringdevice configured to monitor skill learning, where the controllerreceives feedback from the monitoring device and alters the parametersof the electrical pulse train of the vagus nerve stimulator.

SUMMARY OF THE INVENTION

Millions of people suffer from chronic problems caused by nerve damage,including loss of motor control and paresthesia. These symptoms oftenpersist even after the reestablishment of nerve connectivity, suggestingthat denervation alone cannot fully account for dysfunction. It iswell-known that nerve damage generates maladaptive neuroplasticity incentral networks attempting to compensate for the loss of peripheralconnectivity. However, it is not known whether this pathologicalhomeostasis is a critical feature responsible for the expression ofperipheral neuropathy symptoms. If pathological central changescontribute to dysfunction, then it is conceived that reversing thechanges in central networks should restore motor and sensory functioneven in the absence of peripheral changes.

Embodiments of this disclosure employ a strategy using brief bursts ofclosed-loop vagus nerve stimulation (CL-VNS) paired with a well-definedrehabilitation and/or regeneration to reverse the pathologicalplasticity caused by severe nerve damage. Reversal of aberrant centralplasticity results in substantial recovery of motor and sensory functionwithout changes in the nerve or muscle, such that plasticity in brainand spinal networks mediate recovery. Anatomical and physiologicalstudies reveal that CL-VNS therapy drives extensive synapticreorganization in central networks. Depletion of acetylcholine in thebrain blocks plasticity and subsequently eliminates functional recovery.These findings demonstrate that manipulations to enhance plasticity incentral networks improves motor and sensory recovery and define CL-VNStherapy as a novel and readily translatable therapy to restore functionafter nerve damage.

Rehabilitation for astereognosis and tactile sensory dysfunction in theclinic is expensive and produces insufficient numbers of trials perweek. At home therapy can be effective with or without the addition ofadjuvant therapies such as vagus nerve stimulation (VNS). The presentinvention allows patients to improve sensory and motor function throughstereognosis practice enhanced by the use of mobile technology.

In one aspect of the invention, a method and system of treatment forperipheral nerve damage of a subject includes targeting reversal ofmaladaptive central network plasticity resulting from the peripheralnerve damage by enhancing plasticity in at least one of a motor or asensory network of the subject. This treatment releases corticalacetylcholine during rehabilitative training to enhance plasticity inthe motor or the sensory network.

In another aspect of the invention, a method and system for treatmentfor peripheral nerve damage applies a closed-loop vagus nervestimulation during a rehabilitation of the damaged peripheral nervewherein a vagus nerve stimulation signal is applied coincidentally withthe rehabilitation. In yet another aspect, the rehabilitation comprisesapplying a stimulus to the sensory network of the subject.

In a further aspect of the invention, a method and system of treatmentfor peripheral nerve damage wherein a closed-loop vagus nervestimulation is applied coincidentally upon completing a successfulrehabilitative task. The successful rehabilitative task comprisesspecific movements or exercises during rehabilitation of the damagedperipheral nerve that meet specified quantitative or qualitativecriteria pre-defined by a therapist or a measurement system. In oneaspect, the method and system comprises pairing the step of applying aclosed-loop vagus nerve stimulation with a regenerative therapy of theperipheral nerve damage wherein the regenerative therapy is as anystrategy that promotes nerve regrowth or reinnervation. In anotheraspect, the regenerative therapy comprises at least one of surgicaltechniques, nerve conduits, treatment with growth factors, electricalstimulation of the damaged nerve, or pharmacological treatments.

A stereognosis training system for a patient is disclosed comprising aset of objects categorized by tactile sensory function wherein anobstruction visually obscures the set of objects from the patient. In anaspect of the present invention, an interactive device in the system isconfigured to select a test object, direct the patient to identify andgrasp the test object from the set of objects and determine if thepatent correctly identified and grasped the test object.

The set of objects of the present invention have many different featuresand aspects. For example, the set of objects have different featuresizes and/or different colors based on tactile sensory function. Oneimportant feature of the set of objects is that subsets of objects canbe chosen to stimulate a particular tactile sensory function. In anotheraspect, the set of objects includes subsets of objects that stimulate aselected receptor group of the somato sensory system or multiplereceptor groups of the somatosensory system. The receptor groups may beselected, for example, from cutaneous receptors, mechanoreceptors,nociceptors and thermoreceptors.

In another aspect, the particular tactile sensory functions includesize, texture, heat conductance, temperature, weight, density,ductility, flexibility, yield-strength, compliance, homogeneity,vibration, friction, viscosity, stickiness, orientation stability andpain.

In other aspects, a subset of objects is chosen to have a common fixedfeature. For example, the subset of objects have the same weight. In yetother aspects, a subset of objects have common varying features. Forexample, subsets of objects have varying ability to stimulate pain, havevarying texture or have varying size. In yet other aspects, a subset ofobjects have one of more common fixed features for a set of tactilesensory functions while also having one or more common varying featuresfor a different set of tactile sensory functions. For example, thesubset of objects have the same size, shape and texture but vary indensity.

In one embodiment of the stereognosis training system, an obstruction isprovided that visually obscures the set of objects from the patient suchas a blindfold. In other embodiments of the stereognosis trainingsystem, the obstruction that visually obscures the set of objects fromthe patient is a curtain or a solid obstruction between the patient'seyes and the set of objects. In each case, the patient's hands remainfree to grasp the set of objects.

In another embodiment of the stereognosis training system, theobstruction that visually obscures the set of objects from the patientis a box comprising a set of solid walls, a floor and an opening orpenetrable wall sufficient for a hand of the patient to be inserted intothe box while obscuring the inside of the box from view of the patient.

In other embodiments, the stereognosis training system is configured toautomatically distribute the set of objects on the floor of the box. Forexample, in one embodiment, the floor is sloping away from thepenetrable wall so that the set of objects are distributed away from thepenetrable wall so that the patient is better able to locate all of theblocks within the box. In another embodiment, the set of objects areautomatically distributed with random placement inside the boxutilizing, for example, a guide for loading and distributing the set ofobjects inside the box.

In another aspect of the present invention it is conceived that theinteractive device be a smart phone or other computer device. There aremany features and programmable aspects of smart phones and computerdevices useful to the present invention. For example, the interactivedevice is further configured to visually identify a test object to thepatient for the patient to retrieve from the box. In another aspect, theinteractive device is configured to audibly identify a test object tothe patient for the patient to retrieve from the box.

In yet another embodiment of the stereognosis training system, anattachment is included for holding the interactive device. Examples ofan attachment may be a transparent shelf attached to the walls of thebox or a transparent shelf attached to a self-supporting structurefurther attached to or sitting upon a desk on which the box is placed.

In another feature of the present invention, the interactive device isfurther configured to accept at least one of a screen tap or an audiblesound to determine if the patient correctly identifies and grasps thetest object. In a related feature, the interactive device is furtherconfigured to automatically determine if the patient correctlyidentifies and grasps the test object without requiring the patient totouch the interactive device or create an audible sound for theinteractive device.

In other aspects of the present invention, the interactive device isfurther configured to determine an ability of the patient to correctlyidentify and grasp a test object in response to a request to retrievethe test object. In yet another aspect, the interactive device isfurther configured to determine an elapsed time from when the patientinserts their hand into the box in response to a request to retrieve atest object until when the patient correctly identifies and grasps thetest object and to further record the elapsed time as the ability of thepatient to correctly identify and grasp the test object. In a furtheraspect, the interactive device is configured to record the determinationthat the patient correctly identified and grasped the test object as ascore and transmit the score to a second device.

In another embodiment, the system is configured to measure and recordthe interaction time that the patient interacts with the interactivedevice, for example when the patient touches the screen of theinteractive device or moves their hand into or out of the field of viewof a camera of the interactive device. Such a measure and recording ofthe interaction time may also provide a measure and recording of therate of movement outside the box, and a measure and recording of whenthe hand moves from inside the box to the field of view of the camera.In yet another aspect, the system measures and records the speed ofmovement and hand position during object exploration.

In another embodiment of the present invention, the stereognosistraining system further comprises a stimulation device for the patientwherein the stimulation device is communicatively attached to theinteractive device. It is further conceived that the interactive devicebe configured to determine whether or not the patient's hand is insertedinto the box and stimulates the patient with the stimulation devicewhile the patient's hand is inserted into the box. In another aspect ofthe stimulation feature, the stimulation device is configured tostimulate the vagus nerve of the patient.

The present invention includes an embodiment for a method for improvingtactile sensory function in a patient using a stereognosis trainingsystem for a patient having a set of objects categorized by tactilesensory function wherein an obstruction visually obscures the set ofobjects from the patient and having an interactive device in the systemconfigured to select a test object, direct the patient to identify andgrasp the test object from the set of objects and determine if thepatent correctly identified and grasped the test object. The method forimproving tactile sensory function comprises the step of assessingtactile recognition with the stereognosis training system to determine aset of tactile sensory deficits and a tactile sensory score. The methodfurther comprises directing the patient to practice tactile recognitionwith the stereognosis training system based on the set of tactilesensory deficits.

In another embodiment, the method for improving tactile sensory functionin a patient further comprises the steps of targeting a target sensorydeficit in the set of tactile sensory deficits for rehabilitation basedon the assessment; selecting a subset of the set of objects based on thetarget sensory deficit; directing the patient via the interactive deviceto retrieve at least one object from the subset of the set of objects;determining whether the patient retrieved the at least one object; and,determining a tactile function score based on whether the patientretrieved the at least one object.

In a further embodiment, the rehabilitation is adjusted by re-selectingthe target sensory deficit for rehabilitation based on the tactilefunction score. Then the method for improving tactile sensory functionis repeated beginning with the step of selecting a subset of the set ofobjects based on the (different) target sensory deficit.

Other embodiments of the method for improving tactile sensory functionin a patient include recording minutes per day of practice with thestereognosis training system, plotting usage history of the stereognosistraining system, tracking a history of tactile sensory scores, sending areminder message to the patient reminding the patient to practicetherapy, triggering simultaneous vagus nerve stimulation based ontactile sensor scores, quantifying hand position and speed of movementduring haptic exploration and retrieval of the at least one object,providing instructions for using the stereognosis training system. Inyet another embodiment a step of tracking a history of tactile sensoryscores and determining improvement in tactile sensory function of thepatient is included. In yet another embodiment, feedback is provided tothe patient based on the improvement in tactile sensory function and thehistory of tactile sensory scores.

In another aspect of the present invention, the foregoing steps of themethod for improving tactile sensory function and the variousembodiments can be performed by the interactive device.

Another embodiment is conceived wherein the method for improving tactilesensory function comprises sensing the patient's hand position andcausing a stimulator device to stimulate the vagus nerve of the patientbased on the patient's hand position.

Objects used in stereognosis training are easily identified visually butchallenging for a stroke or spinal cord injury patient to identify bytouch alone. Object sets have been conceived that have different levelsof difficulty for identification by touch (active exploration,stereognosis). The most distinct objects differ in multiple tactilesensory functions (dimensions). Difficult contrasts in stereognosis willbe of a single tactile sensory function (dimension). For example,objects sets are conceived to challenge individual dimensions such aslength, curvature, texture roughness and weight.

Object weight and center of gravity can be adjusted by producing hollowspaces in 3D printed objects or by adding weights to hollow spaces.Differences in weight and associated momentum change (during movements)will allow for mass estimation.

It is also conceived that placement of objects in specific locationswould be advantageous for use and assessment of tactile memory. Thisbecomes more important when a greater number of objects and greaterlevel of difficulty in training is required.

For example, the objects in each set are a different color so it is easyto ensure the right objects for a particular tactile sensory functionare in each set and returned there after each discrimination.Additionally, each object is optionally labeled with a number (thatcannot be felt). Object sets of real world objects are also conceivedsuch as a brush, a spoon, a set of keys, a tube of toothpaste or pair ofeye glasses (for example). For severely impaired individuals, objectsets are conceived to have an upward facing handle or putty (whichadheres to the shape of the hand when grasping).

In addition to object sets, a system and method is disclosed for thepatient to assign tasks, interact with an object set and complete taskswith the object set is conceived. For example, a box to obscure visionis provided without obscuring hand access wherein the box can be loadedfrom above so locations of the objects are not known at the beginning ofeach task.

An interactive device is integrated with the stereognosis trainingsystem to direct, monitor and provide feedback for patient activity. Inan illustrative embodiment, a smart phone operating a programmedapplication uses an on-board camera to detect that the patient's handhas entered the box. The box (or another embodiment of stereognosisapparatus) is modified to hold the phone and angle the cameraappropriately to make observations and allow for patient interaction.Such an event can be time-stamped and utilized to triggertime-coordinated external stimulation, such as vagus nerve stimulation.In one embodiment, an easily identifiable object is worn on the hand(for example colored bracelet) to confirm when the hand of the patientis engaged with the object set. In another embodiment, the pattern ofthe patient's active hand exploration is determined to analyzestimulation timing.

A clinical tool is conceived to confirm improvement in stereognosis andtactile sensory function by measuring individual dimensions of density,texture, compliance, shape, and so forth. Repeated testing and use ofquantitative measures (average time required to identify objects withspecific physical differences) will yield more reliable and moresensitive assessments of sensory function compared to current clinicalmethods.

The stereognosis system of the present invention provides a much neededimprovement in the art of stereognosis assessment, rehabilitation andtreatment in that: it is inexpensive from a hardware/software andtreatment perspectives (no therapist is required), it is transportablewith potentially lightweight construction and easy setup, it can providechallenging and directed practice for the patient in individualdimensions and in dual or multiple physical dimensions, it can utilizereal world objects, the objects sets are color coded, the objects covera wide range of difficulty to cover the wide range of impairment fromeasy to grasp objects to more difficult, it blocks visual cues duringobject exploration but provides clear visual feedback when needed usingan interactive device, it can provide motivating encouragement andreminders through the interactive device, it is practical for home useand the treatment can be paired with external stimulation (for examplevagus nerve stimulation) using the interactive device, it can reduceinactivity and contractures through grasp-search-release-repeatstructure, it can detect and record history of practice time and assessprogress in training, it is normed to real tactile sensory function datato set appropriately difficult tasks as the patient progresses, videoand audio advice are provided to the patient to guide therapy based onperformance.

A stereognosis training system comprises: a box with a hand accessopening; a camera with a lens; a computing device with a video inputcoupled to the camera; an interior surface within the box that isreachable by a patient via the hand access opening; and a set of objectslocated within the box and on the interior surface; wherein at least oneof the set of objects is optically tracked using the camera and thecomputing device to generate a time domain stream of data on at leastone of location, rotation, and vibration for the at least one object ofthe object set. In a preferred embodiment, the computing device has asignal output to trigger a closed loop nerve stimulation to the patient.In a preferred embodiment, a mirror is optically coupled between thelens of the camera and the interior surface. In a preferred embodiment,the camera and the computing device are integrated components of amobile device such as a smart phone, tablet or laptop. In a preferredembodiment, the mobile device is mechanically connected to an adaptorthat is mechanically coupled to the enclosure to hold the mobile deviceand optically couple the lens of the camera to the mirror. In apreferred embodiment, the enclosure has an arm rest positioned beneaththe hand access opening. Optionally, the arm rest can be removable. In apreferred embodiment, the enclosure has a chute to introduce the objectset onto the interior surface.

A method of stereognosis training comprises: cuing a patient to identifyand retrieve at least one member of an object set; and opticallytracking a hand of the patient and the at least one member of the objectset using computing device having a camera and a microprocessor togenerate a time domain stream of data on the hand of the patient and theat least one member of the object set. In a preferred embodiment, themethod comprises automatically triggering a vagus nerve stimulation (CLVNS) to the patient with a signal output from the computing device.

In a preferred embodiment, the system and method comprise providingwithin the box a set of objects (object set) where each of the objectsis characterized by a different color. In this way, the camera andmicroprocessor can track each of the objects. Tracking can includerecognizing and locating. This recognizing and locating by color can beverified based on the pixels that the camera associates with the color.In this way, each object can be identified by a color and a number ofpixels. Each of the pixels can have three or four component intensitiessuch as red, green, and blue, or cyan, magenta, yellow, and black.

In an alternative embodiment, the system and method comprise providingat least one fiducial on each of the plurality of objects that uniquelyidentifies each object and that indicates both scalar position of eachobject and directional orientation of each object. The use of at leastone fiducial on each of the objects enables readily available augmentedreality tools for mobile devices to generate a time domain stream ofdata on at least one of position, rotation, and vibration for each ofthe objects of the object set.

A nerve stimulation signal can be triggered based on the time domainstream of data meeting criterion associated with a performancethreshold. The performance threshold can be moving the object that wascued and/or removing the object that was cued from the box (from theview of the camera). In a preferred embodiment, the signal isautomatically handled in a closed loop from the microprocessor to animplanted vagus nerve stimulator via a network interface and a wirelesslocal area network. The time domain stream of data can be reported to aremote device such as a clinical device monitored by a therapist or anapplication server that is connected to a database. The determination ofwhether the time domain stream of data meets the criterion associatedwith the performance threshold can be performed with software by thecomputing device and/or the remote device, without the need for atherapist or clinician. This is an important advantage of the inventionbecause obviating the need for a therapist or clinician dramaticallyreduces costs. It also makes the determination more objective and lesssubjective.

In an embodiment of the present invention, the computer is configured todetect and measure hand insertion into the stereognosis system. Thetablet computer also detects and measures duration times for a patientsearching for an object and/or retrieving the object from the box.

It is an object of the present invention to engage the patient inpractice of stereognosis leading to rehabilitation of tactile sensoryfunction. In so doing, an interactive device records minutes of use perday, number of attempts and number of successes.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features believed characteristic of the illustrativeembodiments are set forth in the appended claims. The illustrativeembodiments, however, as well as a preferred mode of use, furtherobjectives and features thereof, will best be understood by reference tothe following detailed description of an illustrative embodiment of thepresent disclosure when read in conjunction with the accompanyingdrawings, wherein:

FIG. 1A is a schematic diagram of a stereognosis training system with ablindfold in accordance with an illustrative embodiment of theinvention.

FIG. 1B is a schematic diagram of a stereognosis training system with anobscuring screen in accordance with an illustrative embodiment of theinvention.

FIG. 2A is a perspective view of a stereognosis training system with abox, an obscuring screen and a curtain in accordance with anillustrative embodiment of the invention.

FIG. 2B is a side view of a stereognosis training system utilizing a boxwith a slope insert, an obscuring screen and a curtain in accordancewith an illustrative embodiment of the invention.

FIG. 2C is a top view of a stereognosis training system utilizing a boxwith a slope insert, an obscuring screen and a curtain in accordancewith an illustrative embodiment of the invention.

FIG. 2D is a side view of a stereognosis training system utilizing a boxwith a centering insert, an obscuring screen and a curtain in accordancewith an illustrative embodiment of the invention.

FIG. 2E is a top view of a stereognosis training system utilizing a boxwith a centering insert, an obscuring screen and a curtain in accordancewith an illustrative embodiment of the invention.

FIG. 3 is a cutaway view of a stereognosis training system according toan illustrative embodiment of the invention.

FIG. 4 is a perspective view of an offset curtain in accordance with anillustrative embodiment of the invention.

FIG. 5A is a network diagram of a system for a stereognosis trainingsystem according to an illustrative embodiment of the invention.

FIG. 5B is a schematic diagram of a computer system architecture for astereognosis training system according to an illustrative embodiment ofthe invention.

FIGS. 6A-6G are schematic diagrams of various sets of objects inaccordance with illustrative embodiments of the invention.

FIGS. 7A-7D are schematic diagrams of object sets that exhibit varyingdegrees of difficulty in a single parameter in accordance withillustrative embodiments of the invention.

FIG. 8A is a summary table of sets where three sets are constructed foreach object type within a range of features and objects in some sets maybe more difficult to distinguish than in other sets in accordance withillustrative embodiments of the invention.

FIG. 8B is a schematic drawing of a cutaway view of an exemplary objectset.

FIG. 8C is a schematic drawing of a cutaway view of an exemplary objectset.

FIG. 9 is a block diagram of a method for assessment for stereognosistraining and rehabilitation according to illustrative embodiments of theinvention.

FIG. 10 is a block diagram of a method for stereognosis rehabilitationaccording to illustrative embodiments of the invention.

FIG. 11 is a block diagram of a method for paired therapy of externalstimulation and stereognosis training according to illustrativeembodiments of the invention.

FIG. 12 is a flow chart depicting a task based sensory rehabilitationtreatment method in accordance with an embodiment of the invention.

FIGS. 13A and 13B are a flow chart depicting a method of softwareprocess in accordance with an illustrative embodiment of the invention.

FIG. 13C is a block diagram of a method for analyzing statistics presentin accordance with an illustrative embodiment of the invention.

FIGS. 14A-14B are a set of bar graphs illustrating reversal ofpathological plasticity restores sensory function after nerve injury inaccordance with an illustrative embodiment of the invention.

FIGS. 15A-15B are a set of bar graphs showing reversal of pathologicalplasticity is necessary to restore sensory function after nerve injuryin accordance illustrative embodiments of the invention.

FIG. 16A is a top view of a stereognosis training system in useaccording to an illustrative embodiment of the invention.

FIG. 16B is a side view of a stereognosis training system according toan illustrative embodiment of the invention.

FIG. 16C is a graph of a benchmarked assessment in accordance with anillustrative embodiment of the invention.

FIG. 17 is a graph plotting duration of time hand in box versus elapsedtime in accordance with an illustrative embodiment of the invention.

FIG. 18 is a graph of performance history for various object sets inaccordance with an illustrative embodiment of the invention.

FIGS. 19A-19H are graphs depicting success rate and correct percentagebased on task difficulty in accordance with an illustrative embodimentof the invention.

FIG. 20 is a graph comparing different signals returned from a cameraover time in accordance with an illustrative embodiment of theinvention.

DETAILED DESCRIPTION OF THE INVENTION

In the description that follows, like parts are marked throughout thespecification and figures with the same numerals, respectively. Thefigures are not necessarily drawn to scale and may be shown inexaggerated or generalized form in the interest of clarity andconciseness.

In the description of the embodiments and experimental details thatfollows, the term “plasticity” means a capacity of a human brain toreorganize itself to form new connections between neurons. The term“rehabilitation” means any standard physical rehabilitative exercise,such as those targeted to improve range of motion or strength, performedwith a therapist or self-guided, and includes the use of rehabilitativedevices. The term “successful rehabilitation” is defined as specificmovements or exercises during rehabilitation that meet specifiedquantitative or qualitative improvement criteria, such as force, speed,range of motion, or stability, as defined by a therapist or ameasurement system. The term “regeneration” or, alternatively,“regenerative therapies,” are defined as any strategy that promotesnerve regrowth or reinnervation, including surgical techniques, nerveconduits, treatment with growth factors, electrical stimulation of thedamaged nerve, or pharmacological treatments. The term “closed-loopvagus nerve stimulation” (CL-VNS) means a neuromodulation strategywherein electrical stimulation of the vagus nerve of a subject occurssubstantially simultaneously to a measured action of the subject. Theterm “open-loop vagus nerve stimulation” (OL-VNA) means a stimulation ofthe vagus nerve of a subject that is not substantially simultaneouslywith a measured action of the subject. The term “substantiallysimultaneous” means within no more than three (3) seconds before orafter the observed patient action.

“Stereognosis” is the ability to perceive or the perception of materialqualities (such as shape) of an object by handling or lifting it to gettactile information. “Astereognosis” is the failure to identify orrecognize objects by palpation in the absence of visual or auditoryinformation.

FIG. 1A shows an illustrative embodiment of stereognosis training as asimple blindfold based stereognosis training system 100. System 100comprises container 103 on support 107 in which set of objects 108 areplaced. Support 102 is attached to support 107. Surface 104 is attachedto support 102. Surface 104 includes transparent window 109. Interactivedevice 110 is positioned adjacent the window. In a preferred embodiment,the interactive device is a tablet counter configured with a downwardfacing camera and an upward facing display. The downward facing camerais positioned to view the container and the blocks through the window.The interactive device can record images of patient 101 interaction withset of objects 108. System 100 also includes blindfold 105 for obscuringthe patients view of set of objects 108.

FIG. 1B shows an illustrative embodiment of stereognosis training system150. System 150 comprises container 113 on support 117 in which set ofobjects 118 are placed. Support 112 is attached to support 117. Surface114 is attached to support 112. Surface 114 includes transparent window119. Interactive device 120 is placed adjacent transparent window 119.The interactive device can record images of the patient 111 interactionwith set of objects 118. Opaque panel 115 is attached to surface 114 andobscures the patient's view of set of objects 118.

FIGS. 2A, 2B, 2C, 2D, and 2E show perspective and cutaway views of analternate preferred embodiments of the stereognosis training system.Training system 200 comprises front wall 204, back wall 207 side walls202 a and 202 b and floor 203 attached together form light tight box201. Set of objects 208 is placed on floor 203, preferably randomlydistributed. Preferably, the area of the floor is sufficient to allowfor considerable haptic exploration, but yet small enough to be easilyportable. Front wall 204 further comprises opening 210. The opening islarge enough to accommodate stroke patients with spasticity, or poormotor control. In one embodiment, the box is approximately 2 foot squarewith a height of about 2 feet. In this embodiment, the opening is about6″×18″. The interior surfaces of the floor and the walls are preferablyrubberized to reduce auditory cues about object identity.

Device support 218 is attached near the top of the box to one or more ofthe front, back and side walls. Device support 218 is comprised of atransparent material which is safe, such as plexiglass. In a preferredembodiment, the device support is positioned at angle 250 relative tothe floor. In this embodiment, angle 250 must be sufficient to allow thecamera to view the entirety of the floor inside the box.

Front wall 204 further comprises curtain 205 to allow a patient toinsert a hand through opening 210 without seeing set of objects 208.Curtain 205 is opaque and preferably black. Further to the visualobstruction of the set of objects from the patient, the box sides arepositioned and of sufficient dimension to obstruct the line of sightfrom the top of the box. The top of the box includes opening 260. In apreferred embodiment, opening 260 is of sufficient size to allow for animpaired patient to drop object sets onto the floor. Adjacent opening260 is guide 206. Guide 206 is attached to back wall 207 and side wall202 a. The guide forms a downward facing ramp which allows easyplacement into the box and assist in randomly distribute them on thefloor.

In FIGS. 2B and 2C, the system further comprises sloped floor section213 which begins at opening 210 and slopes downward at angle 270 towardback wall 207. Preferably angle 270 is about 30°. In a preferredembodiment, the sloped floor section is about 4″ long and spans theentirety of front wall 204 directly below the opening. The sloped floormay be accomplished by a removable insert.

In this embodiment, interactive device 220 includes field of view 276which can be seen to encompass the entirety of sloped floor section 213and floor 203. The purpose of the slope floor is to distribute the setof objects away from front wall 204 so that blocks are not placedbeneath the patient's palm or wrist and are more easily found during asearch.

In FIGS. 2D and 2E, training system 200 further comprises centeringinsert 214 adjacent floor 203.

The centering insert is further comprised of sloping section 214 a, 214b, 214 c and 214 d. Section 214 a begins at the lower surface of opening210 and extends to floor 203 and contacts sections 214 b and 214 d.Similarly, section 214 b begins at side wall 202 a and extends to floor203, contacting sections 214 a and 214 c. Likewise, section 214 c beginsat back wall 207 and slopes toward floor 203, contacting sections 214 band 214 d. Section 214 d begins at side wall 202 b and slops towardfloor 203, contacting section 214 c and 214 a. Each of the sectionsmakes an angle of approximately 30° from the floor, shown in thisexample as angle 272 and 274. The insert comprises an inverted pyramid.However, in other embodiments, the insert can comprise an invertedfrustoconical surface beginning at the sidewalls and terminating at thefloor. The centering floor system could also be integrated with thefloor. The purpose of the insert is to distribute the set of objectsaway from walls so that they are more easily accessible to the patientduring use.

The opening must be such that objects will not escape when loaded fromthe top. The sloped sections from provide this function.

Referring to FIG. 3, a preferred embodiment of training system 400 willbe described.

Training system 400 is comprised front wall 406, back wall 407, sidewall 408 and floor 409. A second side wall is provided but is not shownin the cutaway view. The side walls and the floor are held in positionby track railing 405. In a preferred embodiment, track railing 405comprises an “X-bar” aluminum extrusion approximately 2″ square. In apreferred embodiment, the walls and the floor are comprised are of rigidplastic material such as Teflon® or Delrin® preferably coated on theinterior with a sound damping surface, such as sound dampening surface482. The sound dampening surfaces are preferably an open cellpolyurethane foam material. In other embodiments, the sound dampeningsurfaces may be applied as a rubberized sound dampening coating on theinterior surfaces of the walls and the floor.

Track railing 405 further supports object entry portal 438. Object entryportal 438, in a preferred embodiment comprises a frustoconical invertedcone 436 terminating in chute 440. Hood 437 is an angular baffleattached to the side walls and back wall 407. The baffle serves todirect objects downward toward the chamber. The hood also prevents lightfrom entering chamber 480 and prevents the patient from a line of sightinto the interior of removable container 485. Chute 440 forms a curveddirectional surface 441 directed toward chamber 480. The walls and thefloor when connected to form a light tight chamber. Positioned withinlight tight chamber 480 is removable container 485. Removable container485 is positioned within chamber 480 adjacent horizontal placement guide455 adjacent front wall 406 and floor 409. Front wall 406 furthercomprises opening 450 adjacent horizontal placement guide 455. Opening450, in a preferred embodiment is covered by offset curtain 448. Offsetcurtain 448 in a preferred embodiment includes overlapping flaps 491 and492, as shown in FIG. 4, as will be further described.

Horizontal ring light 442 is held in position above removable container485 by track railing 405. In a preferred embodiment, ring light 442circles the interior periphery of the box and is comprised of white LEDillumination of approximately 6000° Kelvin color temperature. Thefrequency of light is important because, it must fully and evenlyilluminate blocks of different colors in order to provide an accuratereflection of each color. Front wall 406 further supports bracket 412.Bracket 412 further supports computing device 410. Adjacent bracket 412is transparent window 420. Transparent window 420 is held directlyadjacent computing device 410 by bracket 412. Computing device 410further comprises a processor and a camera, which will be furtherdescribed. The camera (not shown) is positioned by bracket 432 towardmirror 430. Mirror 430 directs light from objects 470 to the camera. Ina preferred embodiment, mirror 430 is placed at approximately a 30°angle with respective to floor 409.

Adjacent opening 450 on horizontal placement guide 455, is blue bar 465.Blue bar 465 includes, in a preferred embodiment, a blue anodizedreflective surface having a defined color temperature and a definedpixel count, as seen by the camera and computing device 410.

Base rail 404 supports arm rest 460 adjacent opening 450. Arm rest 460is supported on the base rail by adjustable bracket 462. Adjustablebracket 462 enables movement of arm rest 460 toward and away fromopening 450 to accommodate different patients. In a preferredembodiment, adjustable bracket 462 is fixed to base rail 404 by areleasable toggle, not shown.

Removable container 485 includes antibounce pad 487 sufficient toprevent objects 470 from moving when dropped through chute 440.

In a preferred embodiment, computing device 410 further comprisesintegrated components of a mobile device, such as a smartphone, tabletor laptop.

Referring to FIG. 4, offset curtain 448 will be described. In apreferred embodiment, offset curtain 448 comprises opposing sets offlaps, such as flap 491 and 492. The flaps are offset in a such afashion that when a hand is inserted, they completely block light fromexiting chamber 480 from opening 450.

FIG. 5A is an architecture diagram of embodiment 500 of a computingdevice preferred for use in the system. Controller 505 is connected tomicrophone 530, HDMI display 520, keypad 525, speaker 535, camera 515,sensor stack 545, light bar 540 and memory 506, as will be furtherdescribed.

Controller 505 is further connected to network interface 555 whichwirelessly communicates with implant 560. Controller 505 communicates towide area network 570, such as the Internet, through Wi-Fi adapter 572.Controller 505 communicates through the wide area network to user device568 and server 574.

Server 574 is connected to monitor 576 and database 578.

Controller 505 draws program instructions for operation andcommunication functions from memory 506.

Implant 560 preferably is ReStore Wireless Vagus Nerve Stimulatoravailable from Teliatry.

Referring then to FIG. 5B, a preferred embodiment of controller 505 willbe described. In a preferred embodiment, the controller is a dedicatedRaspberry Pi 3 Model B available from Adafruit Industries. Thecontroller includes processor 580. In a preferred embodiment, processor580 is a Broadcom BCM 2837 1.2 GHz Quad-Core processor. Controller 505includes two USB 2.0 ports 579 and 585. USB port 579 is connected toWi-Fi adapter 572 which provides local Internet connection. In oneembodiment, USB port 585 is connected to keypad 525. In anotherembodiment, USB port 585 is connected to a Bluetooth communicationmodule or network interface. Wi-Fi adapter 572 in a preferred embodimentis Product ID 1012 USB Wi-Fi module 802.11 B/G/N available fromAdafruit. In a preferred embodiment, network interface 555 is aBluetooth RF transceiver, such as HC-11 Module 433 MHz wirelessBluetooth module available from Alibaba at www.alibaba.com.

Controller 505 further includes HDMI adapter 581 connected to HDMIdisplay 520. In a preferred embodiment, HDMI display 520 includesintegrated microphone 530, speaker 535 and keypad 525. Controller 505includes processor 580 connected to memory 506 via access slot 582.Controller 505 further includes GPIO connector 583. Sensor stack 545includes optical sensors positioned adjacent opening 450, as previouslydescribed. LED display stack 584 is operatively connected to theprocessor through GPIO connector 583. Sensor stack 545 and LED displaystack 584 are both operatively connected to the processor through theGPIO connector. In a preferred embodiment, the sensor stack includesoptical detectors having both an LED and phototransistor onboard. In apreferred embodiment, the sensor stack includes four QRD 1114 opticaldetectors available from Sparkfun at www.sparkfun.com. The opticaldetector provide reflective sensitivity without the need for separatephototransistors and LED's. In another preferred embodiment, sensorstack includes a fully automatic PIR motion sensor such as VithalHC-SR501 available from Alibaba at www.alibaba.com. LED display stack584 further comprises an array of white LED's connected through currentlimiting resistors to GPIO connector 583. Camera 515 is connected todedicated video connector 516 from which it communicates with processor580.

Instructions stored in memory 506 and executed by processor 580 causeprocessor 580 to interact with the system. Processor 580 receivessoftware updates from server 574 through Wi-Fi adapter 572. Theprocessor communicates with user device 568 also through Wi-Fi adapter572, as will be further described.

In a preferred embodiment, processor 580 is coupled to a remoteapplication server via the wide area network. A database is coupled tothe remote application server. The remote application server and itsassociated database can be accessed by processor 580 and/or by a remoteclinical device via wide area network 570.

FIGS. 6A-6G provide illustrative embodiments of object sets, however theinvention is not limited by the object sets shown. Many otherembodiments of object sets are possible. Some primary considerations forselecting object sets are: (1) for tactile sensory dysfunction, objectsets map to tactile sensory functions, (2) for more severe brain injuryor stroke, objects sets include real world objects, and (3) forperipheral and somatosensory dysfunction object sets map to the specificsensory features that are most impaired. In one embodiment, each objectset relates to a different tactile sensory function and each object sethas a distinctly different color so that the sets can be kept separateand easily identified in the directions and feedback given to thepatient.

For example, in FIG. 6A, green set 6301 is for size discrimination,yellow set 6302 is for shape discrimination, orange set 6303 is forcontour discrimination, purple set 6304, red set 6305 and black set 6306are for profound sensory loss where multiple features are needed todiscrimination between objects. In some embodiments, object sets ofdiffering color relate to the difficulty of tactile recognition.

In FIG. 6B, further exemplary sets of objects are shown as 6310 and6312. In example 6310, objects may be constructed of wood, for example,and be numbered according to size, shape and function. In example 6312,a randomized arrangement of the set of objects is shown.

In FIG. 6C, a further exemplary set of objects 6320 is shown. In thisexample, the numbers of “points” on each object increases from right toleft. As can be seen, object “A” includes four points. Object “B”includes five points. Object “C” includes six points. Object “D”includes seven points. Object “E” includes twelve points. A typical taskfor a patient with objects 6320 would be to locate the object with aspecific number of points within a specific time limit.

In FIG. 6D, a further exemplary a set of objects 6330 is shown. In thisexample, both solid and hollow objects are included in the object set.Objects 6330 may be 3D printed as those shown or constructed of othermaterials or by other methods, for example, flexible or rigid injectionmolded polyvinyl chloride. A typical task for a patient with objects6330 would be to locate either a hollow or solid shape within a specifictime limit.

In FIG. 6E, a further exemplary set of spherical objects 6340 varying insize and texture. Objects 6340 is designed to test dual tactile sensoryfunction. Objects 6340 includes large ball “a” with diamond shapedindentions, smaller ball “b” with fine lines, medium ball “c” withmedium thickness lines, small ball “d” with very fine lines and smallsmooth ball “e”. An illustrative task with objects 6340 would be tolocate the balls in ascending or descending order according to size.Objects 6340 would be considered a “difficult” object set because thedifferences between the sizes is small.

A further exemplary set of objects 6342 is shown in FIG. 6E. Objects6342 includes three objects, large ball with diamond shaped indentions“a”, medium ball with medium thickness lines “c” and small ball andsmooth ball “c”. Objects 6342 would be considered “easier” than objects6340 because the differences in sizes and textures between the balls ismore significant.

FIG. 6F shows a set of real world objects 6350 that may be used with theinvention. Objects 6350 includes everyday objects with very differentshapes and textures which can be used for profound stereognosisdeficits. An illustrative task with objects 6350 would be to find theglasses, find the brush, then find the keys.

FIG. 6G shows multiple sets of objects for an illustrative embodiment ofa stereognosis training method. Objects 6361, objects 6362 and objects6363 include three objects of decreasing degree of tactile recognitionbetween the objects included the set. For example, objects 6361 hasobjects that are very distinct in tactile recognition whereas objects6363 has three objects that are less distinct and more difficult todistinguish in tactile recognition. Objects 6364, objects 6365 andobjects 6366 include more than three objects of varying tactilerecognition, with the most recognizable differences in objects 6364 andthe least recognizable differences in objects 6366.

A stereognosis training method is prescribed at step 6370 to beginstereognosis training prescribing tasks using sets of three objects withdistinctly different shapes and texture, including for example,smooth/hard, heavily textured, soft/pliable shapes. At step 6371, themethod proceeds to prescribe tasks with more challenging objects thatdiffer in fewer properties or with less distinction in tactilerecognition than in step 6370. Step 6372 proceeds to prescribe taskswith more objects of a mixed distinction and difficulty in tactilerecognition.

Stereognosis deficits can result from one or more of poor motor control,poor proprioception (joint position) and poor tactile sensation (touch).Object differences can be designed to require judgement of a singlefeature or a combination of features (as in everyday objects).Differences between objects in an object set will be adjusted to createuniform differences in difficulty.

FIGS. 7A-7D show examples of object sets that exhibit varying degrees ofdifficulty in a single parameter. In this example, the objects vary onlyin length and color. For example, object 701 is the shortest, whileobject 705 is the longest. The weight, texture and shape of the objectsis held constant. In a preferred embodiment, each of the objects variesin density so that its weight is the same, approximately 500 grams. Theobjects vary by ½″ each and range from 2″ to 4″ in length.

Object 701, object 702, object 703, object 705 and object 704 can bedivided into sets of differing difficulty based on their relativelengths.

FIG. 7B shows an “easy” difficulty set comprised of object 701 andobject 705, which exhibit the greatest difference in length, therebybeing the easiest to recognize.

FIG. 7C shows a “medium” difficulty set comprised of object 701, object703 and object 705. The objects in this object set are more difficult totell apart because the differences in length are smaller.

FIG. 7D shows “hard” difficulty set comprised of object 702, object 703and object 704. These objects are the most similar in length and hencethe most difficult to tell apart.

In FIG. 8A, a further exemplary set of objects is shown. A table of fourobject sets. The set of objects 800 can categorized into several subsetsaccording to length, texture, shape and weight. Row 801 identifiessubsets of objects based on length. The basic object shape for thesubset of row 801 is a cylinder. Row 802 identifies subsets of objectsbased on texture. Row 803 identifies subsets of objects based on shape.Row 804 identifies subsets of objects based on weight. The subsets ofobjects may be further categorized by basic object 805, type 806,difficulty ranges “easy” 807, “medium” 808 and “hard” 809 and range ofdifficulty column 810, and Somatosensory Receptor column 827.

The subsets of objects are further identified by color. Each subset oftwo objects include two different primary colors. In one preferredembodiment, these colors are red and green. In subsets of objectsincluding three objects, three different primary colors are applied. Ina preferred embodiment, these three primary colors are red, yellow andgreen. The objects in each subset are required to be different colors sothat they may be differentiated by the computer system.

The basic object for subsets in row 801 can be seen to be a cylinder.The basic object for the subsets in row 802 can be seen to be a“tri-toroid”. The basic shape for objects in row 803 can be seen to beflat and three dimensional. The basic shape of objects in row 804 areseen to be generally cylindrical. The basic shapes for each row ofobject subsets can change so long as each of the basic shapes remainsconstant for each subset in each row.

Referring then to row 801, subset 811 is comprised of two cylindricalobjects which range in length from 2″ to 4″. Subset 811 is categorizedas “easy.” Subset 812 is comprised of three objects ranging in lengthfrom 2″ to 3″ to 4″. Subset 812 is categorized as “medium” indifficulty. Subset 813 is comprised of three cylindrical objects rangingin size from 2.5″ to 3″ to 3.5″. Subset 813 is categorized as “hard” indifficulty. The primary receptor type stimulated 828 for row 801 objectsis mechanoreceptor Ruffin endings.

Referring to row 802, subset 815 is comprised of two tri-toroidalobjects having textures “a” and “b”. Texture “a” includes a rangebetween features of about 0.045 cm². The texture of object “b” includesa different texture with a range between features of about 0.045 cm².Subset 815 is characterized as “easy” in difficulty. Subset 816comprises three tri-toroidal objects having textures “a”, “b” and “c”,respectively. Texture “a” and texture “c” have a range between featuresof feature of about 0.09 cm². Object “b” has a smooth texture andtherefore is designated as a feature size of 0. Subset 816 ischaracterized as “medium” in difficulty. Subset 817 comprises threetri-toroidal objects having textures “a”, “b” and “c”. The texturefrequency of texture “a” is approximately about 0.045 cm². The texturefrequency of texture “c” has a feature size of about 0.045 cm². Thetexture “b” is smooth and therefore is characterized by a featurefrequency of 0 cm². Primary stimulation type 829 for row 802 objects ismechanoreceptor Meissner corpuscles.

Referring then to row 803, object subset 818 is comprised of twoobjects. In this example, the objects comprise of flat, threedimensional cylinder and a flat three dimensional triangle. Subset 818is comprised as “easy” in difficulty. The range of points in subset 818is 0 and 3. Subset 819 is comprised of three objects. The shapes of theobjects comprise a flat three-dimensional cylinder, a flatthree-dimensional square and a flat three-dimensional triangle. Subset819 is characterized as “medium” in difficulty. The range of points insubset 819 is 0, 3 and 4. Subset 820 is comprised of three objects, aflat three-dimensional hexagon, a flat three-dimensional square and aflat three-dimensional five pointed star. Object subset 820 ischaracterized as “hard” in difficulty. The primary receptor typestimulated 830 for row 803 objects is mechanoreceptor Merkel's disks.

Range 814 indicates that the objects in row 801 can have a range inlength between 2″ and 4″. Range 824 indicates that the objects in row802 can vary between 0 and 0.09 cm² in feature size. Range 825 indicatesthat the object in row 803 can vary between 0 and 6 points. The objectsin row 804, range between 42 and 85 grams.

Referring then to row 804, subset 821 is comprised of two objects.Objects weighing 42 grams and an object weighing 85 grams. Subset 821 iscategorized as “easy” in difficulty. Object subset 822 is comprised ofthree objects. One object weighs 42 grams, one object weighs 64 gramsand one object weighs 85 grams. Subset 822 is characterized as “medium”in difficulty. Subset 823 is comprised of three objects, one weighing 53grams, one weighing 64 grams and one weighing 74 grams. Object subset823 is characterized as “hard” in difficulty. The primary receptor typestimulated 831 for row 804 objects is proprioceptor.

The object subsets in row 801 are each of equal weight, have the sametexture, and have the same shape. Each of the objects and each of thesubsets varies only by length.

The objects in row 802 are of the same length, shape, and weight andvary in only texture.

The objects in row 803 are of the same length, are the same generalsize, texture and weight and vary only in shape.

The object subsets in row 804 are the same length, texture and shape andvary only in weight.

As can be seen, the object subset allow only one parameter, namelylength, texture, shape or weight to vary within each subset.

Referring to FIG. 8B, an exemplary subset of objects will be described.This subset comprises object 850 and object 890. The two objects are thesame size, the same weight, the same texture but different colors. In apreferred embodiment, object 850 is red and object 890 is green. Thesingle parameter varied between these objects is tactile vibration.Hence, the primary receptor stimulated is Pacinian corpuscles.

Object 850 is comprised of body 858 which includes hollow internalchamber 851. Internal chamber 851 includes motor 852 operativelyconnected to off center weight 854 by shaft 853. Motor 852 isoperatively connected to battery 855 and switch 856. When switch 856 isactivated, current is supply from the battery to the motor therebyrotating the off center weight in order to create a vibration. In apreferred embodiment, motor 852, shaft 853 and off center weight 854 areavailable prepackaged as a vibration motor available from Uxcell. Inthis embodiment, the motor is three fold motor weighing approximately 24grams and vibrating at approximately 1,000 rpm. Battery 855 comprises athree volt lithium battery weighing approximately 35 grams. Switch 856is single pole single throw switch weighing approximately 2 grams. Body858 in this embodiment weighs approximately 20 grams. The total weightof object 850 then is approximately 81 grams.

Object 890 comprises body 888 and centrally located weight 891. Body 888weighs approximately 20 grams. Central weight 891 weighs approximately61 grams. In a preferred embodiment, body 858 and body 888 are bothcomprised of brightly colored polypropylene plastic. Weight 891 iscomprised of a light zinc alloy.

Referring to FIG. 8C, an exemplary subset of objects will be described.This subset comprises object 860, object 870 and object 892. The threeobjects are the same size, the same weight, the same texture, butdifferent colors. In a preferred embodiment, object 860 is red, object870 is yellow, and object 892 is green. The single parameter variedbetween these objects is tactile temperature. Hence, the main receptorsstimulated are the thermo-receptors and nociceptors.

Object 860 is comprised of body 868 which includes hollow internalchamber 861. The body is probably a light zinc aluminum alloy. Internalchamber 861 includes heater 862 operatively connected to battery 865 andswitch 866. The internal chamber is backfilled with epoxy to stabilizethe components. The heater is positioned against an interior surface ofthe internal chamber to facilitate heat transfer. In a preferredembodiment, heater 862 is a standard rectangular 1.5 volt ultrathinflexible heater Model No. TSA0100016ARO.705, 3.19 watt heater availablefrom Pelonis Technologies, Inc. of Exton, Pennsylvania. When switch 866is activated, current is supplied from the battery to the heater inorder to increase the object's temperature. The total weight of object860 then is approximately 95 grams.

Object 870 is comprised of body 878 which includes hollow internalchamber 871. Internal chamber 871 includes Peltier junction 872operatively connected to battery 875 and switch 876. When switch 876 isactivated, current is supply from the battery to the Peltier junction inorder to decrease the object's temperature. In a preferred embodiment,the Peltier junction is a TEC-30-36-127 Peltier cooler module assemblycreated at 3 amps at approximately 15.4 volts available from WakefieldThermal Solutions, Inc. of Pelham, N.H. The internal chamber isbackfilled with epoxy to stabilize the components. The junction ispositioned against an interior surface of the internal chamber tofacilitate heat transfer. The total weight of object 870 then isapproximately 95 grams.

Object 892 comprises body 893 and centrally located weight 894. Body 893weighs approximately 20 grams. Weight 894 is comprised of a light zincalloy with sufficient voids to demonstrate a weight of approximately 95grams.

In FIG. 9, method 970 for stereognosis training is shown. Method 970begins at step 972, by providing a stereognosis training system having aset of objects that stimulate a set of tactile sensory functions, anobstruction obscuring the set of objects from a patient and, optionally,an interactive device. The interactive device is preferably programmedto select a test object, direct the patient to identify and grasp thetest object from the set of objects and determine if the patentcorrectly identified and grasped the test object.

At step 974, tactile recognition of the patient is assessed bydetermining a set of tactile sensory deficits of the patient anddetermining a tactile sensory score based on the tactile sensorydeficits.

At step 976, the stereognosis system, preferably via the interactivedevice, directs the patient to practice tactile recognition and focusingthe practice on the set of tactile sensory deficits found in step 974.

Referring to FIG. 10, a method of rehabilitation is further described asmethod 1080. At step 1085, one or more target sensory deficits forrehabilitation are selected based on the set of tactile sensorydeficits. At step 1086, a subset of objects are selected that are knownto stimulate the target tactile sensory deficits. At step 1087, theinteractive device directs the patient to retrieve at least one objectfrom the subset of objects.

A determination is made, at step 1088, as to whether or not the patientaccurately retrieved the object. The determination can be made in anumber of ways. In one embodiment, the interactive device displays apicture of the object. The patient then simply lifts or retrieves theobject into sight and compares it visually to the picture and eitherpresses a button on the interactive device or audibly speaks into theinteractive device to provide a response that the object was correctlyor incorrectly selected. The interactive device determines the responseand records it. In another embodiment, the interactive device recordsvideo images of the patient's hand and the object being selected and,through image processing techniques and/or visual cues attached to theobject, determines whether the object was correctly or incorrectlyselected.

At step 1089, a tactile sensory score is determined based on the resultfound in step 1088. In one embodiment, the tactile sensory score is thepercentage of correct objects found in the subset of objects, which isupdated at step 1089 as each object is retrieved.

At step 1090, the tactile recognition ability of the patient isre-assessed for changes in tactile sensory deficits. For example, whenthe tactile sensory score for a target sensory deficit crosses athreshold, then the next highest tactile sensory deficit found in theoriginal assessment or in a new assessment is selected as the targetsensory deficit and the method repeats beginning with step 1085.

Referring to FIG. 11, a method for paired therapy using the stereognosistraining system is shown as method 1100. At step 1105, a patient's handposition is sensed during stereognosis training to determine if thepatient's hand is engaged in searching for an object within a set ofobjects. Preferably the time of engagement with the set of objects andthe duration of the engagement with the set of objects is determined instep 1105. At step 1110, a stimulator device, capable of stimulating thevagus nerve of the patient, stimulates the patient's vagus nerve at aprescribed time and for a time duration determined by the time ofengagement with the set of objects and the duration of engagement withthe set of objects. For example, the 0.5 second trains of vagus nervestimulation is delivered during active object engagement. Stimulation istypically off for at least 5 second between stimulation events.

Referring to FIG. 12, a flow chart depicts CL-VNS treatment duringsensory rehabilitation of a subject. Method 1200 is applicable forsensory dysfunction resulting from nerve damage and in particular,peripheral nerve damage in which one or more rehabilitation tasks of thesubject's sensory network is prescribed. During a rehabilitationsession, an evaluation is made at step 1202 of whether or not thesession is complete. If so, the method moves to step 1205 and concludes.If not, the method moves to step 1204. A subject is required toperforming a task that is monitored via a monitoring and triggeringsystem 1207.

At step 1204, a determination is made as to whether or not the subjectis engaged in performing the rehabilitation task. If so, the methodmoves to step 1206 and, optionally also to step 1208. If not, the methodreturns to step 1202.

At step 1206, the rehabilitation task may be further monitored todetermine if the subject was “successful” in completing therehabilitation task according to a pre-defined threshold for success(for example, engage a switch twice, lift an object for a given amountof time and so forth). If so, then the method moves to step 1209. Ifnot, then the method returns to step 1204.

At step 1208, a neural stimulus is applied to the subject's vagus nerveimmediately upon sensing the subject's engagement with therehabilitation task. The method then returns to step 1202. At step 1209,a neural stimulus is applied to the subject's vagus nerve immediatelyupon sensing the subject's “successful” completion of the rehabilitationtask. In a preferred embodiment, only step 1209 is required for vagusnerve stimulation during rehabilitation treatment. In other embodimentsof method 1200, either or both of steps 1208 and 1209 may be executed.In other embodiments, the time, duration or pulse width of VNSstimulation may vary between steps 1208 and 1209.

Referring to FIGS. 13A and 13B, method 1300 of a software processresident in memory 506 will be described.

In general, the sensorimotor task is both mediated and monitored bysoftware loaded into the controller. Instructions to the operator aredisplayed on the screen, as well as an image of the object theparticipant is to retrieve. The participant then reaches into the box,finds the object by touch, retrieves it, and drops in back into the boxthrough the chute on the top of the box. The controller uses a camera todetect the presence of the participants hand by detecting the apparentsize of a blue bar adjacent the opening and color of the objects insidethe box. Because each object in a set is a different color, the color isused to determine whether or not each object returned by the participantis correct. If it was correct, a new object is displayed; if not, taskrepeats. The software records the object set difficulty, the objecttarget and the elapsed time between the beginning of the task and theend of the task.

At the conclusion of the sensor motor task a message is sent to theparticipant via text message or email that includes a report ofprogress. During the sensor motor task, the camera view and a runningsummation of progress is sent to and recommended by the server, and maybe monitored by a remote computer. The summation of progress includes atable of trial and error, subject type, elapsed time per task, andaverage elapsed time. The server compiles statistics from all the sensormotor tasks. The controller also may send sensor motor task schedules toparticipants informing them of scheduled task times.

Referring then to FIG. 13A, at step 1302, the method begins.

At step 1304, the processor enables the cameras. At step 1306, theprocessor enables the lights interior to the box. At step 1308, theprocessor analyzes the image provided by the cameras. At step 1310, theprocessor decides whether or not blocks are present in the camera image.If so, the method moves to step 1312. If not, the process moves to step1314. At step 1312, the processor displays a message to remove anyblocks that are present in the box. The method then returns to step1304.

At step 1314, the processor receives a selection of difficulty from thekeypad.

At step 1315, the processor loads one of any number of block tables aschosen by the keypad input. A preferred embodiment of a set of blocktables is shown below:

TABLE 1 EASY Block ID Pixel Count Color A1 100 Red A2 150 Green A3 175Yellow

TABLE 2 MEDIUM Block ID Pixel Count Color B1 125 Red B2 175 Green B3 195Yellow

TABLE 3 HARD Block ID Pixel Count Color C1 130 Red C2 180 Green C3 200Yellow

At step 1316, the processor chooses the next target block. In apreferred embodiment, the next target block is different from theprevious target block.

At step 1318, the processor displays instructions to the patient. In apreferred embodiment, the instructions include instructions to insertthe set of blocks corresponding to the block table into the entry portalof the device.

At step 1320, the processor analyzes the camera image. At step 1322, theprocessor decides whether or not blocks are present in the camera image.If not, the process returns to step 1318. If so, the processor proceedsto step 1324. At step 1324, the processor analyzes whether or not theblocks present in the camera display are the same blocks as those in thecorresponding block table. In a preferred embodiment, the processoranalyzes both the color and the pixel count for each block and compareseach one to the color and pixel count in the corresponding block table.In this step, each block must match the color and the pixel count forthe table, with no extraneous blocks and no missing blocks for themethod to return “true.” If the correct blocks are not present, themethod returns to step 1312. If the correct blocks are present, themethod moves to step 1326.

At step 1326, the processor analyzes the pixel count in the blue startbar present in the image. If the pixel count is equal to the totalpredetermined pixel count for the blue start bar, then the processorassumes that the patient has not inserted his hand into the hand portal,and returns to step 1318. If the pixel count is not equal to the totalpredetermined pixel count for the blue start bar, then the processorassumes that the patient has inserted his hand into the hand portal andproceeds to step 1328.

Referring then to FIG. 13B, at step 1328, the processor starts thetimer. At step 1329, the processor sends a signal to the impact, tostart VNS. At step 1330, the processor again observes the blue pixelcount image from the start bar in the camera image. If the blue pixelcount is the same, then the processor assumes that the patient's hand isstill in the hand portal and proceeds to step 1332. At step 1332, if atime limit has not expired then the processor returns to step 1330. Ifthe time limit has expired, then the processor proceeds to step 1334. Atstep 1334, timeout display message is sent from the processor to thedisplay. At step 1336, the processor returns to step 1302.

At step 1330, if the blue pixel count is equal to the total, then theprocessor assumes that the patient's hand has been withdrawn from thehand portal and moves to step 1337. At step 1337, the processor sends asignal to the implant to stop VNS. At step 1338, the processor stops thetimer. At step 1340, the processor retrieves the image from the camera.At step 1342, the processor decides whether or not the correct block ismissing from the camera image. If the correct block is missing from thecamera image, then the processor moves to step 1344. At step 1344, theprocessor records the time lapsed. At step 1346, the processor recordsthe block that is missing. At step 1348, the processor displays amessage to the patient. At this step, in a preferred embodiment, theprocessor may display a reward “image” or otherwise reward the patientfor correct block choice. At step 1350, the processor receives an inputfrom the patient as to whether or not to continue. If not, the processormoves to step 1352. If so, the processor moves to step 1354 and returnsto step 1302.

If at step 1342, the correct block is not missing from the image, theprocessor moves to step 1356. At step 1356, the processor records theelapsed time. At step 1358, the processor records the block is missingfrom the image. At step 1360, the processor displays a negative messageto the patient and may apply negative feedback. At step 1362, theprocessor displays an image on the display requesting a decision fromthe patient as to whether or not to continue. If so, the processor movesto step 1364 and returns to step 1302. If not, the processor moves tostep 1352. At step 1352, the processor analyzes the current statisticspresent in memory, as will be further described.

At step 1366, the processor provides a report to the patient, and to theserver.

At step 1368, the process ends.

Referring then to FIG. 13C, step 1352 will be further described.

At step 1370, the processor records a summation of the number ofsuccessful test results.

At step 1372, the processor records a running summation of the number ofunsuccessful tests.

At step 1374, the processor records a running summation of the time forsuccessful tests.

At step 1376, the processor records a running summation for the time forunsuccessful tests.

At step 1378, the processor determines a ratio of the number ofsuccessful tests to the number of unsuccessful tests.

At step 1380, the processor determines a ratio of the running total ofsuccessful time to the running total of unsuccessful time.

At step 1382, the processor determines a trend in the number of success.In a preferred embodiment, a “positive” or “negative” trend is reported.An “positive” trend is determined if the average daily number ofsuccessful is greater than the running summation of the number ofsuccessful tests. A “negative” trend is determined when the number ofdaily successful tests is below the running average of successful tests.

At step 1384, the successful tests and the successful test ratio, thesuccessful time to the unsuccessful time ratio, and the success trend isreported to the user.

At step 1386, all calculated statistics noted above are reported to theserver.

At step 1388, the processor reports a predetermined schedule ofpreferred times for rehabilitation therapy and lengths of rehabilitationare reported to the user.

At step 1390, the processor sends a text message or email to the user asa reminder to conduct therapy according to the schedule.

At step 1392, the processor returns.

EXAMPLES

Specific exemplary embodiments will now be further described by thefollowing, nonlimiting examples which will serve to illustrate in somedetail various features of the invention. The following examples areincluded to facilitate an understanding of ways in which embodiments ofthe present disclosure may be practiced. However, it should beappreciated that many changes can be made in the exemplary embodimentswhich are disclosed while still obtaining like or similar result withoutdeparting from the scope of embodiments of the present disclosure.Accordingly, the examples should not be construed as limiting the scopeof the present disclosure.

Example 1

This example is based on experimental results from laboratory rats thatshow reversal of pathological plasticity restores sensory function afternerve injury. The results also show reversal of pathological plasticityis necessary to restore sensory function after nerve injury.

CL-VNS provides precisely-timed release of neuromodulators, includingacetylcholine, during rehabilitation. Rats underwent completetransection and repair of the median and ulnar nerves in the rightforelimb. After six weeks to allow reinnervation to occur, short burstsof vagus nerve stimulation were delivered coincident with forelimbrehabilitative training (CL-VNS). Two control groups that eitherdecoupled VNS from rehabilitation or depleted acetylcholine in the brainwere included to control for VNS effects independent of centralplasticity, including potential effects on reinnervation. The examplesdescribed below show that CL-VNS reversed the maladaptive centralreorganization resulting from nerve damage without influencingperipheral nerve or muscle health, and subsequently enhanced recovery ofmotor and sensory function. These data demonstrate a causal role forcentral plasticity in dysfunction after nerve injury and introducesCL-VNS paired with motor and/or tactile rehabilitation as a uniquetherapy having unexpectedly advantageous results.

Referring to FIG. 14A, sensory threshold in grams is plotted on thevertical axis. The horizontal axis of FIG. 14A is a separation ofdifferent groups of rats as follows. Group 1405 shows left paw resultsfrom an experimental group that received rehabilitation. Group 1410shows left paw results from an experimental group that received VNS andrehabilitation. Group 1415 shows left paw results from an experimentalgroup that received delayed VNS. Group 1420 shows left paw results foran uninjured control group. Group 1425 shows right paw results from anexperimental group that received rehabilitation. Group 1430 shows rightpaw results from an experimental group that received VNS andrehabilitation. Group 1435 shows right paw results from an experimentalgroup that received delayed VNS. Group 1440 shows right paw results forthe uninjured control group.

Referring to FIG. 14B, right forelimb use in percent is plotted on thevertical axis. The horizontal axis of FIG. 14B is a separation ofdifferent groups of rats as follows. Group 1450 shows right paw forelimbuse percent results from an experimental group that receivedrehabilitation. Group 1460 shows right paw forelimb use percent resultsfrom an experimental group that received VNS and rehabilitation. Group1470 shows right paw forelimb use percent results from an experimentalgroup that received delayed VNS. Group 1480 shows right paw forelimb usepercent results for an uninjured control group.

FIG. 14A shows that sensory thresholds in the injured paw weresignificantly increased, consistent with a loss of sensation followingnerve injury (Two-Way ANOVA, main effect of paw, F[1,41]=79.93,p=1.13×10⁻¹⁰). VNS+Rehab significantly improved tactile sensation in thedenervated forepaw (right) compared to both Rehab and Delayed VNS(F[2,20]=6.35, p=0.008). This reduction in sensory threshold in theinjured right paw toward uninjured is an advantageous unexpected result.No change was observed in the uninjured forepaw (left) (F[2,20]=2.22,p=0.14). FIG. 14B shows that VNS+Rehab improved spontaneous forelimb useduring exploration on the cylinder task compared to both Rehab andDelayed VNS. This increase in injured paw use toward uninjured is anadvantageous unexpected result.

Referring to FIG. 15A, sensory threshold in grams is plotted on thevertical axis. The horizontal axis of FIG. 15A is a separation ofdifferent groups of rats as follows. Group 1505 shows left paw resultsfrom an experimental group that received rehabilitation. Group 1510shows left paw results from an experimental group that received VNS andrehabilitation. Group 1515 shows left paw results from an experimentalgroup with depletion of acetylcholine that received VNS andrehabilitation. Group 1520 shows left paw results for an uninjuredcontrol group. Group 1525 shows right paw results from an experimentalgroup that received rehabilitation. Group 1530 shows right paw resultsfrom an experimental group that received VNS and rehabilitation. Group1535 shows right paw results from an experimental group with depletionof acetylcholine that received VNS and rehabilitation. Group 1540 showsright paw results for the uninjured control group.

Referring to FIG. 15B, right forelimb use in percent is plotted on thevertical axis. The horizontal axis of FIG. 15B is a separation ofdifferent groups of rats as follows. Group 1550 shows right paw forelimbuse percent results from an experimental group that receivedrehabilitation. Group 1560 shows right paw forelimb use percent resultsfrom an experimental group that received VNS and rehabilitation. Group1570 shows right paw forelimb use percent results from an experimentalgroup with depletion of acetylcholine that received VNS andrehabilitation. Group 1580 shows right paw forelimb use percent resultsfor an uninjured control group.

FIG. 15A shows that sensory thresholds in the injured paw weresignificantly increased, consistent with a loss of sensation followingnerve injury (Two-Way ANOVA, main effect of paw, F[1,29]=51.7,p=1.97×10⁻⁷). VNS+Rehab significantly improved tactile sensation in thedenervated forepaw (right) compared to both Rehab and ACh−:VNS+Rehab(F[2,14]=7.54, p=0.008). This reduction in sensory threshold in theinjured right paw toward uninjured is an advantageous unexpected result.No change was observed in the uninjured forepaw (left) (F[2,14]=0.31,p=0.74). FIG. 15B shows that VNS+Rehab improved spontaneous forelimb useduring exploration on the cylinder task compared to both Rehab andACh−:VNS+Rehab (depletion of acetylcholine in rats that receiveequivalent VNS paired with rehabilitation). The acetylcholine depletedprevention of VNS-dependent reversal of pathological plasticity inACh−:VNS+Rehab and the increase in VNS+Rehab injured paw use almost backto uninjured are both advantageous unexpected results.

Example 2

This second example is based on experimental results from humanpatients. To quantify stereognosis scoring using the variousstereognosis object sets, discrimination of different stereognosisobject sets are benchmarked versus standard assessments such asFugl-Meyer upper extremity scale (UEFM), Action Research Arm Test(ARAT), Wolf Motor Function Test (WMFT), Stroke Impact Scale (SIS), Boxand Block test, 9-hole peg test, grip and pinch force, two-pointdiscrimination, tactile threshold, and proprioception.

Referring then to FIGS. 16A and 16B, the experimental setup will bedescribed. FIG. 16A is a top view from the camera of an experiment inprocess. As can be seen, patient's hand 310 is reaching through curtain311 and toward objects 320, 330 and 340. The objects in this object setcorrespond to subset 819. Similarly, FIG. 16B shows a cutaway side viewof the apparatus used for this experiment. Patient's hand 310 can beseen reaching toward objects 330 and 340. Tablet computer 350 includingcamera 360 observes patient's hand in movement via mirror 370, as shownin FIG. 16A. Once the experiment task was completed the target blockremoved was placed back in chute 380 where it was returned to the floorof the device.

Referring to FIG. 16C, benchmarking relationship 1600 between a standardstroke score and a stereognosis score for a group of patients is shown.

To quantify stereognosis scoring using the various stereognosis objectsets, discrimination of different stereognosis object sets werebenchmarked versus standard assessments such as Fugl-Meyer upperextremity scale (UEFM), Action Research Arm Test (ARAT), Wolf MotorFunction Test (WMFT), Stroke Impact Scale (SIS), Box and Block test,9-hole peg test, grip and pinch force, two-point discrimination, tactilethreshold, and proprioception. An example of a benchmarking relationshipbetween a standard stroke score and a stereognosis score for astereognosis object set (or multiple sets) is shown in FIG. 16C. In anembodiment of the present invention, the interactive device of thestereognosis system is programmed to evaluate the stereognosis score ofa patient assessment and apply the benchmarking relationship.

X-axis 1602 represents standard stroke “score” for a patient. Thestandard stroke score is provided in “points” and reflects an integersum of several subscores based on a clinical evaluation. For example,zero points is awarded for no performance (such as inability to completetest). 1 point is awarded for poor performance, 2 points are awarded fornormal or slightly below average performance, 3 points is awarded forabove average performance. 4 points is awarded for good performance. They-axis 1604 represents stereognosis score for the same patient. Thestereognosis score is provided in number of objects successfullyretrieved in a predetermined 1 minute time interval. Each of the datapoints 1606, 1608, 1610, 1612, 1614, 1616, 1618, 1620, 1622, 1624, 1626and 1628 represent two tests for the same patient and the resultingstandard stroke score and stereognosis therapy score.

Diagonal line 1630 indicates the mean average of all tests as can beseen, the diagonal line shows that for each individual patient, thestandard stroke scores generally correlates positively to thestereognosis scores.

FIG. 17 is a time series plot 1750 of the duration that a patient's handis inside the box engaging the set of objects to perform a task versusthe elapsed time for the task to be completed. Time series plot 1750shows patient engagement times 1751 (shown as dots) with thestereognosis system. Analysis of time series plot 1750 further indicatesappropriate timing for external stimulation. Time marks 1752 showappropriate intervals for external stimulation (time that stimulation isstarted and duration of stimulation in time). For example, at time marks1752, vagus nerve stimulation is applied to a patient, at a specifictime and for a duration of time, based on the patient's currentengagement time with the blocks (measured by the duration of a handbeing in the box). In this example, the duration of the stimulation isabout 3 seconds. The stimulation can be seen to be deliveredapproximately simultaneously to the conclusion of the task.

Referring to FIG. 18, a plot 1860 of use history and tactile sensoryimprovement over time, is shown. Sets of objects and performance historyplots are color coded to match task difficulty and tactile sensoryfunction. For example, a patient is first given a task of a set ofpurple objects and the percentage of correct attempts is recorded andshown as graph 1861. When reaching a plateau percentage, the patient isgiven a task for a set of green objects which are slightly moredifficult for tactile recognition. The patient's progress is recorded asa percentage of correct attempts and plotted in graph 1862. Whenmastering the green object tasks, the training program continues withthe patient given tasks for yellow objects and thereafter a task blueobjects based on mastery of the task for yellow objects. The results areshown in graph 1863 and graph 1864, respectively. Simultaneous to thepurple, green, yellow and blue tasks, the training program begins tointroduce tasks for red objects having a difficult level of tactilerecognition. The patient's progress with the red object tasks aretracked and plotted as graph 1865. While gathering the tactile sensoryresults in graph 1861, graph 1862, graph 1863, graph 1864 and graph 1865the interactive device can make suggestions and confirm the number andcategory of objects used. The early and sustained improvement in thepercent correct for the much more difficult object set of 5 hard objectsshown in the segments of graph 1865 is an advantageous unexpected resultfor tactile training paired with CL VNS. The interactive device can beconfigured to suggest changes to the object set to make the task easieror more difficult as needed. Furthermore, the interactive device canadjust the level of vagus nerve stimulation and trigger the stimulationbased on task performance in the use history.

Example 3

This third example is based on experimental results from human patients.FIGS. 19A, 19C, 19E and 19G show performance as measured by success rateon sets of all difficulties from each object type. The object sets canbe seen to correspond to these of FIG. 8A. Success rate is an aggregatedversion of the search time indicating the number of successfulretrievals per minute of search time. This can be termed objectselection rate. It can be used to describe performance in a singlesession or performance overall. In each figure blue (the taller bargraph of each of the three pairs in a given figure) indicates controlsubjects (n=4), and red (the shorter bar graph of each of the 3 pairs ina given figure) indicates impaired subjects (n=9).

Of note, FIG. 19C shows that success rate (object selection rate) fortexture for the impaired group 1910 did not go down with the progressionfrom easy to medium to hard as it did with the other 3 object types.This is an advantageous unexpected result because it shows that thetexture type object sets remained equivalently challenging (plasticityeliciting) for the impaired participants even while the participantsaccumulated more experience with the task.

FIGS. 19B, 19D, 19F and 19H show performance as measured by percentcorrect on sets of all difficulties from each object type. Percentcorrect is defined as the percent of retrievals that found the correctobject and can be averaged over all sessions to describe a participant'soverall performance. The grey lines indicate the chance performance forpercent correct.

Also of note, FIG. 19D shows that percent correct for texture for theimpaired group 1920 went up with the progression from easy to medium tohard in contrast to the decline or steady state with the other 3 objecttypes. This is an advantageous unexpected result because it shows thatthe impaired participants continued to improve with texture type objectsets in absolute terms even while the object sets became more difficult(overcoming maladaptive central plasticity). In view of the resultsshown in FIGS. 19C-19D, it may be an advantageous rehabilitationstrategy for impaired participants to devote relatively more trainingtime to texture object sets compared to the other types of object sets.

Referring then to FIG. 20, a comparison of difference signals returnedfrom the camera versus time, for five independent test are shown. Thedifference signal is related to the number of pixels received by thecamera for various colors. Hand difference signal 2050 indicates thetotal pixel count for the blue line adjacent the hand opening. Blockdifferent signal 2060 indicates the cumulative pixel count for allblocks of all colors observed by the camera over time, on the floor ofthe container. Hand inside signal 2070 indicates the period of time thatthe patient's hand was inside the box. Block return indicator 2080indicates the time when the blocks were reintroduced into the chute, asrecorded by onboard sensors connected to the processor.

Referring then to Test 1, it can be seen that the pixel count for theblock differential signal 2060 a increased from 0 to approximately13,500 over the space of approximately 2.25 seconds. The blockdifferential signal then returns to 0. Correspondingly, handdifferential signal 2050 a shows a decrease in blue pixels by nearly2,000 pixels indicating that the patient's arm is extended over at leasta portion of the blue bar. Hand inside signal 2070 a indicates that thepatient's arm was inside the box for approximately 1.2 seconds. Blockreturn indicator 2080 a indicates that the blocks were returned to thechute after approximately 3 seconds. Block differential signal 2060 bindicates that the blocks were returned to the floor of the box in about3 seconds and 4.25 seconds.

Referring to Test 2, block differential signal 2060 c indicates a risein pixel count from 0 to about 3,000 and then returning back to 0 overthe period of about 5 seconds to about 6 seconds. Correspondingly, handdifferential signal 2050 b indicates the patient's arm was extended overthe blue bar from about 5 seconds to about 6 seconds. Hand inside signal2070 b indicates that the patient's hand was inside the box from about 5seconds to about 6 seconds. Block return indicator 2080 b indicates thatthe blocks were returned to the chute at about 6.25 seconds. Blockdifferential signal 2060 d indicates that the blocks returned to thefloor of the box between about 6.5 seconds and 8 seconds.

Referring to Test 3, block differential signal 2060 e indicates that theblocks were present and moved on the floor of the box from about 9.5seconds to about 11.5 seconds. Correspondingly, hand differential signal2050 c indicates that the pixel count for the blue bar decreased betweenabout 9.5 seconds and about 11 seconds. Hand inside signal 2070 cindicates that the patient's hand was inside the box from about 9.5seconds to about 11.5 seconds for a total of about 2 seconds. Blockreturn indicator 2080 c indicates that the blocks were returned to thechute at approximately 12 seconds. Block differential signal 2060 findicates that the blocks were returned to the floor of the devicebetween about 12 seconds and about 12.75 seconds.

Referring to Test 4, block differential signal 2060 g indicates that theblocks were present and moved on the floor of the box from about 12.5seconds to about 14 seconds.

Correspondingly, hand differential signal 2050 d indicates that the bluebar was reduced in pixel count from about 12.5 seconds to about 14seconds. Hand inside signal 2070 d indicates that the hand was insidethe box from about 13 seconds to about 14 seconds. Block returnindicator 2080 d indicates that the blocks were returned to the chute atabout 14.5 seconds. Block differential signal 2060 h indicates that theblocks were present on the floor of the device between about 14.8seconds and 15.5 seconds.

Referring to Test 5, block differential signal 2060 i indicates that theblocks were present and moved on the floor of the device between about16.8 seconds and 18 seconds. Correspondingly, hand differential signal2050 e indicates that the blue pixel count of the blue bar was reducedbetween about 16.8 seconds and about 17.8 seconds. Hand indicator signal2070 e indicates that the hand was inside the box from about 16.8seconds to about 17.8 seconds. Block return indicator 2080 e indicatesthat the blocks were returned through the chute at about 18.5 seconds.Block differential signal 2060 j indicates that the blocks were presenton the floor of the device between about 18 seconds and 19 seconds.

The descriptions of the various embodiments of the present inventionhave been presented for purposes of illustration, but are not intendedto be exhaustive or limited to the embodiments disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art without departing from the scope and spirit of the describedembodiment. The terminology used herein was chosen to best explain theprinciples of the embodiment, the practical application or technicalimprovement over technologies found in the marketplace, or to enableothers of ordinary skill in the art to understand the embodimentsdisclosed here.

1. A method for treating sensory dysfunction resulting from peripheralnerve damage in a subject having a sensory network and a vagus nervecomprising the steps: selecting one or more prescribed rehabilitationtasks of the sensory network; providing a prescribed rehabilitation taskto the subject to perform; providing a monitoring and triggering systemfor the prescribed rehabilitation task; determining if the subject isengaged in performing the prescribed rehabilitation task using themonitoring and triggering system; applying a first electrical stimulusto the vagus nerve when the subject is engaged in performing theprescribed rehabilitation task; determining if the subject issuccessfully in performing the prescribed rehabilitation task; and,applying a second electrical stimulus to the vagus nerve upondetermining that the subject is successfully performing the prescribedrehabilitation task.
 2. The method of claim 1, further comprising:evaluating whether a rehabilitation of the subject is complete based ona signal from the monitoring and triggering system; and, ending arehabilitation session if the rehabilitation is complete.
 3. The methodof claim 1, wherein the step of applying the first electrical stimulusfurther comprises applying the first electrical stimulus for apredetermined period of time.
 4. The method of claim 1, wherein the stepof applying the first electrical stimulus further comprises applying thesecond electrical stimulus for a predetermined period of time.
 5. Themethod of claim 1, wherein the step of providing the monitoring andtriggering system further comprises: providing a vagus nerve stimulator;providing a container; providing a set of objects, movably disposed inthe container; providing a camera, with a view of the set of objects;and, providing a processor, having a memory, operatively connected tothe camera and the vagus nerve stimulator, controlling the vagus nervestimulator.
 6. The method of claim 5, wherein the step of applying thefirst electrical stimulus further comprises: sending a first controlsignal from the processor to the vagus nerve stimulator; and, whereinthe step of applying the second electrical stimulus further comprisessending a second control signal from the processor to the vagus nervestimulator.
 7. The method of claim 6, further comprising: providing adisplay, operatively connected to the processor; and, providing a set ofprogram instructions with instructions that when executed cause themethod to: display at least one object, of the set of objects, on thedisplay.
 8. The method of claim 7, further comprising: providing a userdevice, operatively connected to the processor; and, providing the setof program instructions with further instructions that cause theprocessor to perform the step of: sending one of a group of the firstcontrol signal and the second control signal, based on a time domainstream of data, related to the set of objects, to the user device. 9.The method of claim 7, further comprising: providing the set of programinstructions with further instructions that cause the processor toperform the steps of: monitoring the container for an ingress and anegress; and, sending one of a group of the first control signal and thesecond control signal based on at least one of a group of the ingressand the egress.
 10. The method of claim 5, further comprising: providinga downward facing mirror, adjacent the camera, directed toward the setof objects.
 11. The method of claim 5, further comprising providing asubset of objects, of the set of objects, for stimulating at least oneof a group of: mechanoreceptors; nociceptors; and, thermoreceptors ofthe subject.
 12. A method of automatically triggering a vagus nervestimulation to treat sensory disfunction resulting from peripheral nervedamage in a subject comprising: providing a vagus nerve stimulator;providing a container; providing a set of objects, movably disposed inthe container; providing a camera, with a view of the set of objects;providing a processor, having a memory, operatively connected to thecamera and the vagus nerve stimulator; providing the memory with a setof program instructions that, when executed by the processor, cause theprocessor to perform the steps of: monitoring the set of objects for atime domain stream of data; and, making a first determination as towhether the subject is engaged in a sensory stimulation task from thetime domain stream of data; sending a first signal to the vagus nervestimulator to apply the vagus nerve stimulation based on the firstdetermination; making a second determination as to whether the subjectis successful in perform the sensory stimulation task from the timedomain stream of data; and, sending second a signal to the vagus nervestimulator to apply the vagus nerve stimulation based on the seconddetermination.
 13. The method of claim 12, further comprising:evaluating whether or not a rehabilitation of the subject is completebased on the time domain stream of data; and, ending a rehabilitationsession if the rehabilitation of the subject is complete.
 14. The methodof claim 12, wherein the vagus nerve stimulation is applied for apredetermined time while the subject is engaged in the sensorystimulation task.
 15. The method of claim 12, further comprising:providing a display, operatively connected to the processor; and,providing the set of program instructions with instructions that whenexecuted cause the processor to: display at least one object, of the setof objects, on the display.
 16. The method of claim 12, furthercomprising: providing a downward facing mirror, adjacent the camera,directed toward the set of objects.
 17. The method of claim 12, furthercomprising providing a subset of objects of the set of objects forstimulating at least one of a group of: mechanoreceptors; nociceptors;and, thermoreceptors, of the subject.
 18. The method of claim 12,further comprising: providing a network interface, connected to theprocessor; providing a network, in communication with the networkinterface; providing a user device, connected to the network; and,providing the set of program instructions with further instructions thatcause the method to perform the step of: sending the first signal, basedon one of a group of the first determination and the seconddetermination to the user device.
 19. The method of claim 12, furthercomprising: providing the set of program instructions with furtherinstructions that cause the processor to perform the steps of:monitoring a portal in the container for an ingress into the portal andan egress from the portal; and, sending the first signal based on atleast one of a group of the ingress and the egress.